UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010038
Receipt No. R000011757
Scientific Title Endeavor Zotarolimus Eluting Stent Post Marketing Surveillance in Japan
Date of disclosure of the study information 2013/02/14
Last modified on 2013/02/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Endeavor Zotarolimus Eluting Stent Post Marketing Surveillance in Japan
Acronym Endeavor PMS Japan
Scientific Title Endeavor Zotarolimus Eluting Stent Post Marketing Surveillance in Japan
Scientific Title:Acronym Endeavor PMS Japan
Region
Japan

Condition
Condition Ischemic Heart Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Responding to the condition set with the marketing approval, according to the provisions of Article 14-4 (re-examination of new medical device) of the Pharmaceutical Affairs of Japan, to assess the efficacy and safty of Endeavor Zotarolimus Eluting Stent in actual clinical setting in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Survival free of Major Adverse Cardiac Events (MACE) at 12 months after index procedure
Key secondary outcomes Cummulative incidence rate of late and very late stent thrombosis (VLST) at 5 years after index procedure

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria N/A
Key exclusion criteria N/A
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Takamoto
Organization Medtronic Japan Co., Ltd
Division name QA-PMS
Zip code
Address 2-14-1 Higashi Shimbashi, Minato-ku, Tokyo 105-0021 Japan
TEL 03-6430-7116
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Oyama
Organization Medtronic Japan Co., Ltd
Division name CV-PMS
Zip code
Address 2-14-1 Higashi Shimbashi, Minato-ku, Tokyo 105-0021 Japan
TEL 03-6430-7686
Homepage URL
Email Koichiro.oyama@medtronic.com

Sponsor
Institute Medtronic Japan Co., Ltd
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2009 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prostecitve consecutive registry

Management information
Registered date
2013 Year 02 Month 14 Day
Last modified on
2013 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011757

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.